Federal Register / Vol. 72, No. 36 / Friday, February 23, 2007 / Notices 8171 

Authority: Section 1833(t) of the Act (42 

U.S.C. 1395l(t)). The Panel is governed by the 

provisions of Pub. L. 92–463, as amended (5 

U.S.C. Appendix 2).(Catalog of Federal 

Domestic Assistance Program No. 93.773, 

Medicare-Hospital Insurance; and Program 

No. 93.774, Medicare-Supplementary 

Medical Insurance Program). 

Dated: February 15, 2007. 

Leslie V. Norwalk, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. E7–3040 Filed 2–22–07; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–2221–N] 

RIN 0938–ZA98 

Medicare, Medicaid, and CLIA 

Programs; Approval of COLA 

(Formerly the Commission on Office 

Laboratory Accreditation) as a CLIA 

Accreditation Organization 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: In this notice, we grant COLA 

(formerly the Commission on Office 

Laboratory Accreditation) deeming 

authority as an accrediting organization 

for clinical laboratories under the 

Clinical Laboratory Improvement 

Amendments of 1988 (CLIA) program. 

We have determined that the 

requirements of the COLA accreditation 

process are equal to or more stringent 

than the CLIA condition level 

requirements, and that COLA has met 

the requirements of subpart E of 42 CFR 

Part 493. Consequently, laboratories that 

are voluntarily accredited by COLA and 

continue to meet COLA requirements 

will be deemed to meet the CLIA 

condition-level requirements for 

laboratories and therefore are not 

subject to routine inspection by State 

survey agencies to determine their 

compliance with Federal requirements. 

They are, however, subject to Federal 

validation and complaint investigation 

surveys conducted by us or our 

designee. 

DATES: Effective Date: This notice is 

effective from February 23, 2007 to 

February 25, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Raelene Perfetto, (410) 786–6876. 

SUPPLEMENTARY INFORMATION: 

I. Background and Legislative 

Authority 

On October 31, 1988, the Congress 

enacted the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA), Public Law 100–578. CLIA 

replaced in its entirety section 353(e)(2) 

of the Public Health Service Act, as 

enacted by the Clinical Laboratories 

Improvement Act of 1967. We issued a 

final rule implementing the 

accreditation provisions of CLIA on July 

31, 1992, (57 FR 33992). Under the CLIA 

program, CMS approves a grant of 

deeming authority to an accreditation 

organization to accredit clinical 

laboratories if the organization meets 

certain requirements. An organization’s 

requirements for accredited laboratories 

must be equal to, or more stringent than, 

the applicable CLIA program 

requirements in 42 CFR part 493 

(Laboratory Requirements). The 

regulations in subpart E (Accreditation 

by a Private, Nonprofit Accreditation 

Organization or Exemption Under an 

Approved State Laboratory Program) 

specify the requirements an 

accreditation organization must meet to 

be an approved accreditation 

organization. We approve an 

accreditation organization for a period 

not to exceed 6 years. 

In general, the approved accreditation 

organization must: 

• Use inspectors qualified to evaluate 

laboratory performance and agree to 

inspect laboratories with the frequency 

determined by us. 

• Apply standards and criteria that 

are equal to, or more stringent than, 

those condition-level requirements 

established by us. 

• Assure that laboratories accredited 

by the accreditation organization 

continually meet these standards and 

criteria. 

• Provide us with the name of any 

laboratory that has had its accreditation 

denied, suspended, withdrawn, limited, 

or revoked within 30 days of the action 

taken. 

• Notify us at least 30 days before 

implementing any proposed changes in 

its standards. 

• If we withdraw our approval, notify 

the accredited laboratories of the 

withdrawal within 10 days of the 

withdrawal. 

CLIA requires that we perform an 

annual evaluation by inspecting a 

sufficient number of laboratories 

accredited by an approved accreditation 

organization as well as by any other 

means that we determine to be 

appropriate. 

II. Notice of Approval of COLA as an 

Accreditation Organization 

In this notice, we approve COLA 

(formerly the Commission on Office 

Laboratory Accreditation) as an 

organization that may accredit 

laboratories for purposes of establishing 

their compliance with CLIA 

requirements. We have examined the 

COLA application and all subsequent 

submissions to determine equivalency 

with our requirements under subpart E 

of part 493 that an accreditation 

organization must meet to be approved 

under CLIA. We have determined that 

COLA complied with the applicable 

CLIA requirements and grant COLA 

approval as an accreditation 

organization under subpart E, as for the 

period stated in the ‘‘Effective Date’’

section of this notice for the following 

specialty and subspecialty areas: 

• Microbiology, including 

Bacteriology, Mycobacteriology, 

Mycology, Parasitology, Virology. 

• Diagnostic Immunology, including 

Syphilis Serology, General Immunology. 

• Chemistry, including Routine 

Chemistry, Urinalysis, Endocrinology, 

Toxicology. 

• Hematology. 

• Immunohematology, including 

ABO Group & Rh Group, Antibody 

Detection, Antibody Identification, 

Compatibility Testing. 

• Pathology, including 

Histopathology, Oral Pathology, 

Cytology. 

As a result of this determination, any 

laboratory that is accredited by COLA 

during the effective time period for an 

approved specialty or subspecialty is 

deemed to meet the CLIA requirements 

for the laboratories found in part 493 of 

our regulations and, therefore, is not 

subject to routine inspection by a State 

survey agency to determine its 

compliance with CLIA requirements. 

The accredited laboratory, however, is 

subject to validation and complaint 

investigation surveys performed by us, 

or by any other validly authorized agent. 

III. Evaluation of COLA Request for 

Approval as an Accreditation 

Organization Under CLIA 

The following describes the process 

used to determine that requirements of 

the COLA accreditation program are 

equal to or more stringent than the CLIA 

condition level requirements, and that 

COLA has met the requirements of 

subpart E of 42 CFR part 493. 

COLA formally reapplied to us for 

approval as an accreditation 

organization under CLIA for the 

following specialties and subspecialties: 


cprice-sewell on PROD1PC61 with NOTICES
8172 Federal Register / Vol. 72, No. 36 / Friday, February 23, 2007 / Notices 

• Microbiology, including 

Bacteriology, Mycobacteriology, 

Mycology, Parasitology, Virology. 

• Diagnostic Immunology, including 

Syphilis Serology, General Immunology. 

• Chemistry, including Routine 

Chemistry, Urinalysis, Endocrinology, 

Toxicology. 

• Hematology. 

• Immunohematology, including 

ABO Group & Rh Group, Antibody 

Detection, Antibody Identification, 

Compatibility Testing. 

• Pathology, including 

Histopathology, Oral Pathology, 

Cytology. 

We evaluated the COLA application 

to meet or exceed our implementing and 

enforcement regulations, and the 

deeming/exemption requirements of the 

CLIA rules. 

We verified that the COLA 

accreditation program requirements and 

methods require the laboratories it 

accredits to be, and that the organization 

meets or exceeds the following subparts 

of part 493 as explained below: 

Subpart E—Accreditation by a Private, 

Nonprofit Accreditation Organization or 

Exemption Under an Approved State 

Laboratory Program 

COLA submitted the specialties and 

subspecialties that it would accredit; a 

comparison of individual accreditation 

and condition-level requirements; a 

description of its inspection process; 

proficiency testing (PT) monitoring 

process; its data management and 

analysis system; a listing of the size, 

composition, education and experience 

of its inspection teams; its investigative 

and complaint response procedures; its 

notification agreements with us; its 

removal or withdrawal of laboratory 

accreditation procedures; its current list 

of accredited laboratories; and its 

announced or unannounced inspection 

process. 

Subpart H—Participation in Proficiency 

Testing for Laboratories Performing 

Nonwaived Testing 

COLA’s requirements are equal to the 

CLIA requirements at § 493.801 through 

§ 493.865. Like CLIA, all of COLA’s 

accredited laboratories are required to 

participate in a CMS-approved 

proficiency test (PT) program for any of 

tests listed in subpart I. COLA also 

encourages its accredited laboratories to 

participate in PT for tests that are 

waived under CLIA. 

Subpart J—Facility Administration for 

Nonwaived Testing 

COLA requirements are equal to the 

CLIA requirements at § 493.1100 

through § 493.1105. 

Subpart K—Quality System for 

Nonwaived Testing 

COLA requirements are equal to the 

CLIA requirements at § 493.1200 

through § 493.1299. COLA makes 

educational material available to its 

accredited laboratories, which provide 

further information on quality 

assurance. As part of good laboratory 

practice and to ensure accuracy, COLA 

encourages development of a QC 

program for tests that are waived under 

CLIA. 

Subpart M—Personnel for Nonwaived 

Testing 

COLA states as general policy that its 

personnel standards for accreditation 

are identical to CLIA. A qualified 

individual must fulfill the 

responsibilities of each required 

position in the laboratory. The 

laboratory director and laboratory 

personnel must meet educational and 

experience requirements. Although 

certain duties of the laboratory director 

may be delegated to qualified 

individuals, the laboratory director 

remains ultimately responsible. We 

have determined that COLA 

requirements are equal to the CLIA 

requirements at § 493.1403 through 

§ 493.1495 for laboratories that perform 

moderate and high complexity testing. 

Subpart Q—Inspections 

We have determined that the COLA 

requirements are equal to the CLIA 

requirements at § 493.1771 through 

§ 493.1780. COLA will continue to 

perform onsite inspections every 2 

years. 

Subpart R—Enforcement Procedures 

COLA meets the requirements of 

subpart R to the extent that it applies to 

accreditation organizations. COLA 

policy sets forth the actions the 

organization takes when laboratories it 

accredits do not comply with its 

requirements and standards for 

accreditation. When appropriate, COLA 

will deny, suspend, or, revoke 

accreditation in a laboratory accredited 

by COLA and report that action to us 

within 30 days. COLA also provides an 

appeal process for laboratories that have 

had accreditation denied, suspended, or 

revoked. 

We have determined that COLA’s 

laboratory enforcement and appeal 

policies are equal to the requirements of 

part 493 subpart R as they apply to 

accreditation organizations. 

IV. Federal Validation Inspections and 

Continuing Oversight 

The Federal validation inspections of 

COLA accredited laboratories may be 

conducted on a representative sample 

basis or in response to substantial 

allegations of noncompliance (that is, 

complaint inspections). The outcome of 

those validation inspections, performed 

by us or our agents, the State survey 

agencies, will be our principal means 

for verifying that the laboratories 

accredited by COLA remain in 

compliance with CLIA requirements. 

This Federal monitoring is an ongoing 

process. 

V. Removal of Approval as an 

Accrediting Organization 

Our regulations provide that we may 

rescind the approval of an accreditation 

organization, such as that of COLA, for 

cause, before the end of the effective 

date of approval. If we determine that 

COLA failed to adopt requirements that 

are equal to, or more stringent than, the 

CLIA requirements, or that systemic 

problems exist in its inspection process, 

we may give it a probationary period, 

not to exceed 1 year to allow COLA to 

adopt comparable requirements. 

Should circumstances result in our 

withdrawal of the COLA’s approval, we 

will publish a notice in the Federal 

Register explaining the basis for 

removing its approval. 

VI. Collection of Information 

Requirements 

This notice does not impose any 

information collection and record 

keeping requirements subject to the 

Paperwork Reduction Act (PRA). 

Consequently, it does not need to be 

reviewed by the Office of Management 

and Budget (OMB) under the authority 

of the PRA. The requirements associated 

with the accreditation process for 

clinical laboratories under the Clinical 

Laboratory Improvement Amendments 

of 1988 (CLIA) program, codified in 42 

CFR part 493 subpart E, are currently 

approved by OMB under OMB approval 

number 0938–0686. 

VII. Executive Order 12866 Statement 

In accordance with the provisions of 

Executive Order 12866, this notice was 

not reviewed by the Office of 

Management and Budget. 

Authority: Section 353 of the Public Health 

Service Act (42 U.S.C. 263a). 

Dated: December 7, 2006. 

Leslie V. Norwalk, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. E7–3025 Filed 2–22–07; 8:45 am] 

BILLING CODE 4120–01–P 


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